Clinical Research Coordinator II

1 day ago


Columbus Ohio, United States Nationwide Children's Hospital Full time
About the Role

We are seeking a highly skilled Clinical Research Coordinator II to join our team at Nationwide Children's Hospital. As a key member of our research team, you will be responsible for managing all aspects of clinical studies, ensuring compliance with regulatory guidelines and protocols.

Key Responsibilities
  • Conduct clinical studies in accordance with study protocols, ensuring subject safety and adherence to good clinical practices.
  • Recruit, consent, and enroll subjects, ensuring compliance with ICH/GCP regulations and subject rights.
  • Coordinate and schedule subject study visits, manage protocol-required data, and perform study procedures according to recognized skill level and certifications.
  • Identify and resolve study implementation and management issues, working with the study team to develop and implement solutions.
  • Assist with study recruitment plans, provide input into study budgets, and manage screening, enrollment, and study participation logs.
  • Create source documents for systematic data collection and protocol execution, and conduct accurate and timely subject data collection.
  • Educate other study personnel on study-specific responsibilities and maintain written documentation of training.
  • Alert the investigator to potential safety risks, protocol deviations, or subject requests for premature study termination.
  • Responsible for regulatory/IRB issues after a study has been initiated, maintaining regulatory binders.
  • Assist the principal investigator in preparing scientific publications and grant proposals.
Requirements
  • Education: BA/BS preferred, Associates degree or equivalent work-related experience required.
  • Certifications: CRA/CRC certification preferred.
  • Skills: Understanding of medical terminology and clinical trials, working knowledge of PCs and word processing and data management software, analytical skills with accuracy and attention to detail, excellent verbal and written communication skills, goal-oriented and self-directive, ability to manage complex projects independently, strong organizational and interpersonal skills, and ability to actively participate as a team player.
  • Experience: Minimum of 18 months experience in clinical research or healthcare field, two years preferred.


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